The Principal Medical Writer, Therapeutic Area Lead, is a key leadership position responsible for determining and driving the medical writing strategy for one or more therapeutic areas within Clinical Development.
As a strategic partner to senior clinical leadership, the Principal Medical Writer, Therapeutic Area Lead, is accountable for the efficient preparation of high quality, strategically aligned medical writing deliverables that support the clinical development, clinical safety and regulatory requirements of a clinical program. He or she is also responsible for the messaging strategy across a program of work, for the provision of strategic input into the development of clinical development plans and submission plans, and for analysing proposed plans, programs, individual studies and related documents for their ability to deliver the information required by the target audience (ie, regulatory authority) in a compelling fashion with accuracy and consistency.
This role has global responsibilities with potential for global reports, participation in global teams and interaction with regulatory agencies in multiple regions.
Leads the Medical Writing contributions to assigned therapeutic area(s). Key accountabilities:
•Maintain a collaborative and strategic partnership with Global Therapeutic Area Leads, Global Clinical Program Directors and Clinical Safety Physicians to ensure understanding of Clinical Development strategy for the therapeutic area and the nature of medical writing services required to deliver on company objectives
•Critiques ability of product strategy (eg, submission plans) to deliver on business objectives or meet regulatory needs, and identify where new or alternative arguments are needed.
•Leads cross-functional teams to develop a messaging strategy across a program of work (eg, building a clinical submission)
•The efficient preparation of medical writing deliverables for assigned clinical program(s) according to budget and timelines
•Forecasting, budgeting, resource planning and resource allocation.
•Managing (Senior) Medical Writer(s) within therapeutic area(s). Coach, train and mentor staff, thereby contributing to successful clinical development, product registration in key regions and commercialisation of new compounds, including important lifecycle management work
Drives and develops the messaging strategy within the therapeutic area to ensure effective communication underpins successful clinical development.
•Responsible for aligning, coordinating and building consistent information and messages across all individual documents within a clinical program, starting with initial strategic plans, continuing through study level documents to final program level deliverables (ie, regulatory submission or publication of key journal articles for a publication plan).
•Interfaces with Global Therapeutic Area Heads, Global Clinical Program Directors and Clinical Safety Physicians to ensure that the communication needs for clinical data are considered early in the development program to enable consistency of data presentation and messaging throughout the clinical development process.
•Analyses proposed plans, programs, individual studies and related documents for their ability to deliver the information required by the target audience (ie, regulatory authority) in a compelling fashion with accuracy and consistency.
•Understands where all intended messages will be located across individual documents within a clinical program, and ensures alignment of messages across documents.
•Understands issues affecting the design of clinical development strategy, and understands how study design, data capture and statistical analysis plan design will affect downstream documents.
•Responsible for ensuring that statements included in the deliverables are accurate and supported by appropriate data.
•Accountable for medical writing deliverable quality and ensures adherence to departmental procedures / practices, and industry / international standards.
•Responsible for the development, implementation and communication of Best Practices, SOPs, templates, work instructions, style guides and content guides to ensure efficient preparation of high quality medical writing deliverables.
•Cultivates an understanding of modern medical writing processes and solutions through survey of relevant literature, attendance at meetings and use of international external networks.
•Responsible for continual improvement of in-house medical writing.
•Provides expert medical writing support to other CR&D and CSL groups where required.
•In collaboration with Director, Medical Writing and Disclosure, ensures appropriate medical writing support for the clinical programs including forecasting, budgeting, resource planning and resource allocation
•Responsible for building and maintaining collaborative relationships with medical writing partner(s) (CRO, vendor, alliance partner, etc) to ensure an effective, efficient, productive and professional working relationship. Participates in vendor governance.
•Participant in bid defense, contract development, work alignment and / or operation meetings.
Post-graduate qualifications (PhD or MD preferred)
• A minimum of 8 years medical writing experience within the biopharmaceutical industry or a contract research organisation.
• A minimum of 3 years in a supervisory role
• A comprehensive understanding of the clinical development process, including the documents that are required at each stage.
• A comprehensive understanding of medical writing processes, standards and issues.
• Demonstrated track record in cross-functional, multicultural and international clinical trial teams.
• Excellent verbal, written and presentation skills.
• Mastery of the English language, with a comprehensive understanding of English grammar and punctuation.
• Prior experience with submissions in Common Technical Document (CTD) format.
• Knowledge of eTechnology related to regulatory submission activities (eCTD, EDMS, Life Cycle Management).
• Expert MS Office skills with a special focus on word processing, tables, spreadsheets, presentations, graphics and templates